Ethical issues in international vaccine research and development.

multi-national vaccine trials, I will refer primarily to the UNAIDS Guidance Document, Ethical Considerations in HIV Preventive Vaccine Research (hereafter, Guidance Document) [1]. This document, which was developed in the mid-1990s, states that its scope is limited to multinational trials of HIV preventive vaccines. However, I suggest that it is more generally relevant to multinational trials, or development programs, for vaccines. This Guidance Document was influential in the development of another major document which provides ethical guidance and direction for research involving humans as subjects, the CIOMS† (Council of International Organizations of Medical Sciences) International Ethical Guidelines for Biomedical Research Involving Human Subjects (hereafter, International Ethical Guidelines) [2] and, indirectly, the World Medical Association’s Declaration of Helsinki (hereafter, Helsinki) [3]. ETHICAL UNIVERSALISM VS. CULTURAL PLURALISM